Current Study
Bronchiectasis | CSL787_2001
This is a global Phase 2 study testing two doses of an inhalant in adults with bronchiectasis. About 450 participants will receive either a high dose, low dose, or placebo via nebuliser for up to 12 months. The study aims to determine whether this medication can delay or reduce lung flare‑ups, improve quality of life, and remain safe and well tolerated.
Study Status
Recruiting
Duration
12 months
Clinic Visits
20
Phone Check-ins
11
Study Overview
Location
Osborne Park
Phase
2b
Study Duration
12 months
Main Entry Criteria
- Diagnosis of non-cystic fibrosis bronchiectasis.
- In the past year, had either:
- 2 or more flare-ups needing oral and/or IV antibiotics for a lung infection.
- 1 flare-up needing oral and/or IV antibiotics for a lung infection, plus an SGRQ total score above 40 at Screening.
- Able to cough up sputum without assistance at Screening.
Main Exclusion Criteria
- History of bronchospasm; bronchiectasis due to cystic fibrosis; primary diagnosis of another pulmonary disorder, including COPD, asthma, or DPB; severe cardiovascular disease, including Stage IV heart failure; or previous lung transplant or placement on a lung transplant waiting list
- Use of immunosuppressive medications, anti-cytokine therapies, or anti-tumour necrosis factor products
- Current treatment for nontuberculous mycobacterial lung disease, allergic bronchopulmonary aspergillosis, or tuberculosis
- Current smokers; former smokers with a >10 pack-year history; or former smokers with a <10 pack-year history who stopped smoking <6 months before Screening
- History of malignancy within the past 5 years, except non-melanoma skin cancer
Assessments
- PROs and other questionnaires Â
- eDiary review Â
- Vital signs and brief physical examination Â
- ECGÂ Â
- Safety and laboratory assessments Â
- FeNO measurement Â
- Impulse oscillometry Â
- Spirometry (pre-bronchodilator)Â Â
- Spirometry (post-bronchodilator)Â Â
- IMP administrationÂ
At a Glance
Clinic Visits
20
Phone Calls
11
Duration
12 months